Label: ELTAMD UV ACTIVE- zinc oxide, titanium dioxide sunscreen cream

  • NDC Code(s): 72043-2600-2, 72043-2600-3, 72043-2600-8
  • Packager: CP Skin Health Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Warnings

    For external use only. Do not use on damaged or broken skin. Stop use and ask physician if rash occurs. When using this product keep out of eyes. Rinse with water to remove. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Active Ingredients

    Zinc Oxide   19.0%   Sunscreen

    Titanium Dioxide   4.0%   Sunscreen

  • Helps prevent sunburn.  If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Helps prevent sunburn.  If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every two hours. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher. Limit time in the sun, especially from 10 am to 2 pm. Wear long sleeved shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

  • Questions

    Questions or Comments?

    1-800-633-8872

  • Other information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    water, caprylic/capric trigylceride, coco-caprylate/caprate, ethyl macadamiate, glycerin, sorbitan olivate, polyglyceryl-6 polyricinoleate, C15-19 alkane, hydrogenated polyisobutene, sodium chloride, triethoxycaprylylsilane, silica, glyceryl beheanate, hydroxyacetophenone, polyglyceryl-2 isostearate, polyhydroxysearic acid, disteardimonium hectorite, 1,2-hexanediol, caprylyl glycol, hydrolyzed jojoba esters, xanthan gum, diemthicone, sclerotium gum, trisodium ethylenediamine disuccinate, lecithin, pullulan, jojoba esters, polygonum aviculare extract, tocopherol, malic acid 

  • Labeling

    UV Active UC 3oz Tube

  • INGREDIENTS AND APPEARANCE
    ELTAMD UV ACTIVE 
    zinc oxide, titanium dioxide sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72043-2600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION190 g  in 1000 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    glycerin (UNII: PDC6A3C0OX)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MALIC ACID (UNII: 817L1N4CKP)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72043-2600-390 g in 1 TUBE; Type 0: Not a Combination Product02/03/2020
    2NDC:72043-2600-22 g in 1 PACKET; Type 0: Not a Combination Product08/24/2021
    3NDC:72043-2600-8234 g in 1 TUBE; Type 0: Not a Combination Product07/06/202211/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/03/2020
    Labeler - CP Skin Health Group, Inc. (611921669)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    CP Skin Health Group, Inc.080170933manufacture(72043-2600)
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